TXA in Revision Total Shoulder Arthroplasty

Arthropathy Shoulder Clinical Trial

Official title:

The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04650698
• Other study ID #: 20-01617
• Status: Terminated
• Phase: Phase 4
• Start date: January 7, 2021
• Est. completion date: March 12, 2023

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision total shoulder arthroplasty. Patients will be randomized to either receive 2 doses of IV TXA, first dose prior to surgical incision and second dose given 3 hours later or to the control group, where no TXA will be administered.

Description:

The objectives of the study are to compare the effectiveness of IV TXA on reducing calculated total blood loss, surgical drain output and hematoma formation in patients undergoing revision total shoulder arthroplasty.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: March 12, 2023
• Est. primary completion date: March 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients older than 18 years old

2. Patients younger than 90 years old

3. Patients undergoing scheduled revision total shoulder arthroplasty

4. Patients who consent to be randomized

Exclusion Criteria:

1. Patients younger than 18

2. Patients older than 90 years old

3. Patients who are pregnant or breast-feeding women

4. Patients who are allergic to tranexamic acid

5. Patients with proximal humerus fracture or fracture sequelae

6. Patients who use estrogen containing medications (i.e. oral contraceptive pills)

7. Patients who have acquired disturbances of color vision

8. Patients with a history of any of the following diagnosis: '

• Subarachnoid hemorrhage

• Active intravascular clotting

• Severe pulmonary disease (FEV <50% normal)

• Plasma creatinine > 115 µmol/L in males, > 100 µmol/L in females, or hepatic failure)

• (Renal impairment serum creatinine > 1.5 times the upper limit of normal NYU)

• Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]

9. Patients who refuse blood products

10. Patients undergoing hormone replacement therapy

11. Patients with diagnosed or self-reported cognitive dysfunction;

12. Patients who are unable to understand or follow instructions;

13. Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;

14. Patients with BMI over 50

15. Any patient that the investigators feel cannot comply with all study related procedures.

Related Conditions & MeSH terms

• Arthropathy Shoulder
• Joint Diseases

Intervention

Drug:
• Tranexamic acid (TXA) injection
IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)

Locations

Country	Name	City	State
United States	NYU Langone Orthopedic Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Calculated Total Blood Loss	The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula: Total blood loss (ml) = 1000 x ?Hb?_loss/?Hb?_i	up to 24 hours post-op
Primary	Total Surgical Drain Output	The floor nurse will also document the amount of blood in the indwelling hemovac surgical drain placed in the operative shoulder joint up to 24 hours. The total surgical drain output will be calculated after 24 hours.	up to 24 hours post-op
Secondary	Number of Participants With Presence of Hematoma	Surgeon will assess for presence of hematoma at the 2-week follow up visit.	2 weeks post-op
Secondary	Number of Participants Who Needed a Post-op Blood Transfusion		2 weeks post-op
Secondary	Average Operative Time		During operation, up to 4 hours